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510(k) K991608

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING by Dermaphylyx, Inc. — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1999
Date Received
May 10, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Dermaphylyx, Inc.

  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K991920 — DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING (August 12, 1999)
  • K991933 — DERMAPHYLYX FOAM ISLAND DRESSING (July 30, 1999)
  • K991609 — DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING (July 20, 1999)
  • K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (June 28, 1999)
  • K990891 — DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING (May 27, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)

Other clearances for product code KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)